Qinprezo regulatory update

Sunesis said FDA “did not support” submission of an NDA for Qinprezo vosaroxin to treat acute myelogenous leukemia (AML) in patients ages >=60 without additional clinical evidence. The company said it is committed to getting U.S. approval for Qinprezo and is still evaluating options for completing a U.S. submission, including conducting additional clinical trials. Sunesis also said EMA officials recommended the company submit an MAA for Qinprezo to treat relapsed/refractory AML patients ages >=60. The company declined to provide a timeline but said it would submit an MAA as soon as possible.

Last year, Qinprezo in combination with cytarabine missed the primary endpoint of improved overall survival (OS) in the Phase III VALOR trial. Sunesis said last month a subgroup analysis of VALOR showed that in patients ages >=60 with refractory and early relapse AML, Qinprezo significantly increased OS, leukemia-free survival and event-free survival (see BioCentury, Oct. 13, 2014 & June 15, 2015). ...